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Acute Lymphoblastic Leukemia Study

This is a research study for people with acute lymphoblastic leukemia (ALL). We want to learn more about the effects of using a combination of a Tyrosine Kinase Inhibitor (TKI), steroids, and blinatumomab compared to treatment with Tyrosine Kinase Inhibitor (TKI) steroids, and chemotherapy. We are doing this study to test the use of a new combination therapy for BCR-ABL In this study,

Age & Gender

18 years ~ 75 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

If you decide to participate in this study, you will be assigned to one of two groups with different medication combinations. You will come on-site for IV infusions as part of your treatment. After an initial two treatment cycles, if you have not had good results, you will move to the other treatment group. If you have good results, your treatment program will only change if your disease worsens or the side effects become too severe. After your treatment is completed you will be asked to return for follow-up visits. You will be asked to have a bone marrow biopsy 3 months after finishing treatment and at other times recommended by your doctor. You will have blood tests throughout your time in the study. Your doctor may recommend more frequent monitoring and additional testing as needed.

In-person visits:
10-15

Total length of participation:
10 years

Looking for Specific Volunteers

Able to participate:

You have newly diagnosed with Philadelphia chromosome positive (BCR-ABL-positive) Acute Lymphoblastic Leukemia (B-ALL)
You had no prior treatment for your leukemia.

Not eligible if:

You have BCR/ABL T-ALL.
You have symptomatic heart disease.
You have detectable uncontrolled hepatitis B/C or HIV.
You have significant organ dysfunction.
You have unstable epilepsy.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Katarzyna Jamieson
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Leukemia)

IRB Number

22-2728

ClinicalTrials.gov

NCT04530565

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